A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

About

Brief Summary

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab (called "study drugs").

The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drugs
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol.
Measurable disease on cross sectional imaging as defined in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow, renal and hepatic function as defined in the protocol
Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.

Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
Diagnosis of mantle cell lymphoma (MCL)
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol
Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
Co-morbid conditions, as described in the protocol
Infections, as described in the protocol
Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase